Summary of medicine characteristics - DEEP RELIEF JOINT PAIN GEL 5% W/W / 3% W/W
Deep Relief Joint Pain Gel 5% w/w / 3% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains 50 mg (5%) ibuprofen and 30 mg (3%) levomenthol.
Excipient with known effect: propylene glycol.
For the full list of excipients, see section 6.1
Gel.
Clear gel with the odour of menthol.
4.1 Therapeutic indications
Deep Relief Joint Pain Gel is indicated in adults and children aged over 12 years.
Relief of rheumatic pain, muscular aches, pains and swellings such as strains, sprains and sports injuries. Also for the relief of the pain associated with non-serious arthritic conditions.
4.2 Posology and method of administration
Posology
For adults, the elderly and children over 12 years
Method of administration
Apply the gel over the affected area and massage gently until absorbed. Repeat as necessary, up to a maximum of three times a day. Not to be repeated more frequently than every four hours.
For each application use about 10 to 40mm (^ to 1^ inches), containing 50–125mg Ibuprofen.
If no improvement is seen after two weeks, consult your doctor.
For external use only.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
Those patients known to be hypersensitive to ibuprofen, levomenthol, or any of the ingredients or sensitive to aspirin, or other NSAIDS including when taken by mouth, or asthmatic patients in whom aspirin or non-steroidal anti-inflammatories are known to precipitate asthmatic attacks, rhinitis or urticaria. Use on broken skin or denuded skin. Simultaneous use on the same site with any other topical medicine. Use in the presence of local infection. Use in the last trimester of pregnancy.
4.4 Special warnings and precautions for use
Paediatric population
Not recommended for children under 12 years of age.
The gel should not be used on or near mucous membranes, nor near the eyes.
Avoid contact with inflamed or broken skin. Discontinue use if rash or irritation develops. Not for use with occlusive dressings.
Always try on a small area first.
As it is known that oral Ibuprofen may worsen an existing renal impairment, or aggravate an active peptic ulcer, patients with a history of renal problems or with an active peptic ulcer should seek medical advice before using topical Ibuprofen products such as Deep Relief Joint Pain Gel.
The hands should be washed after applying the product, unless they are being treated.
Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration.
If anyone swallows the gel he or she should contact his or her doctor or nearest casualty department.
If anyone experiences any unwanted effects, if there is no improvement, or the condition is aggravated, he or she should consult his or her doctor.
By extrapolation from other routes of administration:
Although this is less likely with NSAIDs intended for topical use compared to oral drugs, the use of Deep Relief Joint Pain Gel, as with any drug known to inhibit cyclo-oxygenase/prostaglandin synthesis, may impair fertility. In women who have difficulty conceiving or who are undergoing investigation of infertility, withdrawal of Deep Relief Joint Pain Gel should be considered.
Keep all medicines out of the sight and reach of children.
For external use only.
Do not store above 25°C
4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
Concurrent use of aspirin or other NSAIDS may result in an increased incidence of adverse reactions. Due to the low systemic absorption in normal conditions, interactions described for NSAIDS administered orally are unexpected.
Paediatric population
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of
pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose
the foetus to:
– cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
– renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;
the mother and the neonate, at the end of pregnancy, to:
– possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
– inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.
Breastfeeding
Ibuprofen is excreted into breast milk in minimal amounts and no effects on the breastfed infant are anticipated. Topical ibuprofen as monocomponent can be used during breastfeeding. However, there is insufficient information on the excretion of levomenthol and its metabolites in human milk. In the absence of sufficient data, the use during breastfeeding is not recommended.
4.7 Effects on ability to drive and use machines
Deep Relief Joint Pain Gel has no influence on the ability to drive and use machines.
No effects are known with topical Ibuprofen.
4.8 Undesirable effects
Skin disorders are most frequently reported: Application site reactions such as, rashes, pruritus and urticaria, drying, reddening, burning sensation, contact dermatitis.
Application site burns have been reported for menthol-containing products. Frequency unknown
Photosensitivity reactions. Frequency unknown.
Other systemic undesirable effects of NSAIDs depend on the quantity of gel applied, the treated area, the integrity of the skin, the duration of treatment, the use of occlusive dressings: although extremely uncommon when administered topically side effects such as abdominal pain, dyspepsia and renal impairment are possible.
Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of:
(a) Non-specific allergic reactions and anaphylaxis.
(b) Respiratory tract reactivity comprising of asthma, aggravated asthma, dyspnoea and bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease (see section 4.3).
© Assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other topical products for joint and muscular pain. ATC Code M02AX
Ibuprofen, a phenylpropionic acid derivative, is a prostaglandin synthetase inhibitor, with analgesic and anti-inflammatory activities when applied topically.
Levomenthol, when applied to the skin, constricts the blood vessels causing a sensation of coldness followed by an analgesic effect. The action of menthol is exerted at the nerve endings of the skin producing mild counter-irritation which is comforting in painful lesions of the muscles, tendons and joints.
Because it is formulated in an aqueous/alcoholic gel, the preparation itself also exerts a soothing and rapid cooling effect when applied to the skin.
5.2. Pharmacokinetic properties
Ibuprofen is applied topically for percutaneous absorption. When applied topically, absorption through the skin has been shown to be about 5% of that taken orally. Systemic concentration reaches a maximum of about 0.6 micrograms per ml some two hours after application.
Levomenthol absorbed through the skin is transported to the liver. Some Phase I metabolism may occur in the skin but most occurs in the liver. The menthol is hydroxylated and then conjugated with glucuronide prior to circulation to the kidneys for excretion in the urine.
5.3 Preclinical safety data
5.3 Preclinical safety dataNon-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ibuprofen and menthol were devoid of mutagenic activity in vitro and in vivo.
6.1
6.2
Propylene glycol Diisopropanolamine Carbomer
Denatured Ethanol Purified water
Not applicable to a topical formulation.
6.3
3 years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Collapsible aluminium tube with epoxy resin lining and high density polyethylene cap filled to an average weight of 100g. The tube is enclosed by a cardboard carton containing a package insert
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
7 MARKETING AUTHORISATION HOLDER
The Mentholatum Company Limited
1 Redwood Avenue
Peel Park Campus
East Kilbride
G74 5PE,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00189/0036
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/01/2015